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AS9100 Gap Analysis [Free Tool]

Find out your level of compliance with AS9100

Instructions: The questions below cover all relevant AS9100 requirements - by filling out the answers, this tool will automatically calculate your company's level of compliance with AS9100.

When answering questions, the following scale needs to be used: 
  • 1 — Not implemented: No process or activity implemented, or little/no evidence of any systematic achievement
  • 2 — Planned: Activity or process is planned but is not implemented, or the implementation just started
  • 3 — In progress: Activity or process is partially implemented, so that its full effects cannot be expected
  • 4 — Mostly implemented: Activity or process is fully or mostly implemented, documented, and relevant people are trained, but monitoring, measurement, and improvement are not systematic
  • 5 — Optimized: Activity or process is fully implemented, documented, and is continuously supervised, measured, and improved; relevant people are trained

4 CONTEXT OF THE ORGANIZATION

4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT


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You need to determine the external and internal issues that are relevant to your organization.

Find out more here: Procedure for Determining the Context of the Organization and Interested Parties.   See Preview

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You need to monitor and review information on internal and external issues.

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES


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You need to determine the interested parties for your QMS and their relevant requirements.

Find out more here: Procedure for Determining the Context of the Organization and Interested Parties.   See Preview

4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM


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You need to determine and document the boundaries and applicability of your QMS by considering external and internal issues, requirements of interested parties, and your products and services.

Find out more here: Scope of the Quality Management System.   See Preview

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES


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You need to establish, implement, maintain, and continually improve a QMS, including all processes needed, as well as interactions and sequences of processes and assigning resources.

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You need to maintain necessary documented information to support the processes and have confidence they are being carried out to plan.

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You need to address customer and applicable statutory and regulatory requirements.

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Your documented information must include: Description of interested parties, Scope of the QMS, Description of QMS processes and their sequence and interactions, and Assignment of process responsibilities and authorities.

5 LEADERSHIP

5.1 LEADERSHIP AND COMMITMENT


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Top management needs to demonstrate leadership of the QMS by accounting for the efficiency of the QMS, promoting QMS principles, promoting improvement, and ensuring resources are available.

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Top management must show leadership with respect to customer focus, customer and statutory requirements, risks and opportunities, and enhancing customer satisfaction.

Find out more here: Procedure for Measuring Customer Satisfaction.   See Preview

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You need to measure and take action on product and service conformity and on-time delivery.

5.2 POLICY


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A quality policy must be established that is appropriate for the organization, provides a framework for quality objectives, and shows commitment to satisfying requirements and continual improvement.

Find out more here: Quality Policy.   See Preview

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The quality policy needs to be available, maintained, communicated, and understood by relevant interested parties.

5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES


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Top management must assign responsibilities and relevant roles for the QMS development, reporting, and maintenance so that it meets the intended goals.

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You must appoint a management representative who has responsibility and authority for the oversight of the QMS, and the organizational freedom and management access to resolve quality issues.

6 PLANNING

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES


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You need to plan for the QMS and consider issues and requirements that determine the risks and opportunities to be addressed.

Find out more here: Procedure for Addressing Risks and Opportunities.   See Preview

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Planning must take place to address the risks and opportunities identified and integrate these into the QMS.

6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM


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You need to establish quality objectives for the QMS that are measurable, monitored, communicated, updated, and documented.

Find out more here: Quality Objectives.   See Preview

6.3 PLANNING OF CHANGES


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When QMS changes are needed, they must be carried out in a planned manner.

7 SUPPORT

7.1 RESOURCES


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You need to determine the resources needed for the QMS, including internal and external resources, people, infrastructure, and the environment necessary for the QMS.

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You need to identify the resources needed for valid monitoring and measurement results for product and service conformity, including measurement traceability, safeguards for measurement, and organizational knowledge necessary for operations. You need to have a register of monitoring and measurement equipment and a process for recall and calibration.

Find out more here: Procedure for Equipment Maintenance and Measurement Equipment.   See Preview

7.2 COMPETENCE


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You need to determine the necessary competence required of persons who will perform functions within the QMS processes.

Find out more here: Procedure for Competence, Training and Awareness.   See Preview

7.3 AWARENESS


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You need to take actions to ensure that persons doing work within the QMS know the quality policy, quality objectives, and how they contribute to the QMS, including the implications of non-conformance. These persons also need to be aware of relevant QMS documentation, how they contribute to product and service conformity and product safety, and the importance of ethical behavior.

Find out more here: Procedure for Competence, Training and Awareness.   See Preview

7.4 COMMUNICATION


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You need to determine the what, when, with whom, how, and who of QMS communication for both internal and external communications relevant to the QMS.

7.5 DOCUMENTED INFORMATION


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You need to set up a process to control documented information of the QMS, including creating and updating, control of use, adequate protection, control of distribution, prevention of use of obsolete documents, and changes. Any electronic document controls must have defined data protection processes.

Find out more here: Procedure for Document and Record Control.   See Preview

8 OPERATION

8.1 OPERATIONAL PLANNING AND CONTROL


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You need to plan and control processes needed for your product or service, including criteria for acceptance, resources needed (including on-time delivery resources), control necessary, and what documented information is needed, including control of planned changes. Additionally, your process needs to include controls for critical items, supporting product and service maintenance, obtaining externally provided products and services, and preventing the delivery of nonconforming products and services.

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You must have a process for operational risk management to identify and control risks through production.

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You need a process for configuration management to ensure identification and control of the attributes of products and services.

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You need to have a process to control processes necessary for product safety.

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You need to implement a process to prevent the use of counterfeit parts.

8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES


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You need to implement processes for customer communication, determining requirements for products and services (including special requirements and operational risks), reviewing requirements of products and services, and updating documents when changes occur. When customer requirements cannot be fully met, you need to have a process to negotiate a mutually acceptable change.

Find out more here: Sales Procedure.   See Preview

8.3 DESIGN AND DEVELOPMENT


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You need to establish, implement, and maintain a design and development process for your products and services that addresses design and development planning, inputs, controls, outputs, and changes (including the ability to provide, verify, test, and maintain products and services).

Find out more here: Procedure for Design and Development.   See Preview

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES


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You need to take steps to ensure that externally provided processes meet requirements by determining the type and extent of control needed and the information needed for external providers. You need processes in place to approve providers, review performance, manage risks, and control documented information created by providers.

Find out more here: Procedure for Purchasing and Evaluation of Suppliers.   See Preview

8.5 PRODUCTION AND SERVICE PROVISION


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You need to implement the controlled conditions necessary for your production and service provision, including necessary documented information, monitoring and measurement, identification and traceability (if necessary), property belonging to customers or external parties, preservation of product or service, control of changes, and post-delivery activities associated with your product and service. Your processes need to include foreign object prevention, control of equipment, tools and software programs, validation and control of special processes, and production process verification.

Find out more here: Procedure for Production and Service Provision.   See Preview

8.6 RELEASE OF PRODUCTS AND SERVICES


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You need to implement planned arrangements to verify that requirements have been met before release of products and services.

8.7 CONTROL OF NONCONFORMING OUTPUTS


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You need to implement a process to identify and control nonconforming outputs of your processes so that they are not unintentionally used until a disposition has been made, and you must maintain documented information for this process. Dispositions of Use-As-Is or Repair can only be used when approved by an authorized design representative and customer authorization.

Find out more here: Procedure for Management of Nonconformities and Corrective Actions.   See Preview

9 PERFORMANCE EVALUATION

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION


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You need to determine the monitoring and measurement needs, how they will be done, and when they shall be performed for the processes of the QMS and customer satisfaction. You must also analyze and evaluate the data and information arising from monitoring and measurement. Customer satisfaction information must include product and service conformity, on-time delivery, customer complaints, and corrective action requests.

9.2 INTERNAL AUDIT


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You need to have audit procedures to evaluate the QMS against the planned arrangements (including effectiveness, proper implementation, and maintenance) at planned intervals, and results must be reported to management.

Find out more here: Procedure for Internal Audit.   See Preview

9.3 MANAGEMENT REVIEW


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Top management must review the data from the QMS to assess the need for change in the QMS, resource adequacy, and the effectiveness of the QMS.

Find out more here: Procedure for Management Review.   See Preview

10 IMPROVEMENT

10.1 GENERAL


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You need to identify opportunities for improvement and implement action to meet requirements and enhance customer satisfaction.

10.2 NONCONFORMITY AND CORRECTIVE ACTION


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When a nonconformity occurs, you must take action to deal with the nonconformity and deal with the consequences, evaluate the need to eliminate the root cause of the nonconformity (including human factor causes), and review the effectiveness of the corrective action taken. You need to flow corrective actions to external suppliers when needed and take action when timely responses are not achieved.

Find out more here: Procedure for Management of Nonconformities and Corrective Actions.   See Preview

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After action is taken, you need to update any risks and opportunities found during the corrective action and update the QMS if necessary.

10.3 CONTINUAL IMPROVEMENT


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You need to continually improve the suitability, adequacy, and effectiveness of the QMS.
Here's the percentage of your compliance with AS9100:
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